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Two commercial EIA
assays demonstrated excellent sensitivity for the detection of HSV
type1-specific antibodies.
Comparative
performance of herpes simplex virus type 1-specific serologic assays from
MRL and Meridian Diagnostics.
Ribes JA, Smith A, Hayes M, Baker
DJ, Winters JL.
Journal of Clinical
Microbiology 2002;40:1071-1072.
Summary:
Question
How do the performances of two glycoprotein G type-specific enzyme
immunoassays compare to that of an immunoblot assay for the detection of
HSV-1 IgG?
Design
A direct comparison of the results obtained by two FDA-approved HSV-1
type-specific EIAs. All EIA discordant and 13.7% of EIA concordant results
were further assessed by an immunoblot assay.
Participants
532 blood donors from the Central Kentucky Blood Center were analyzed.
Description of Tests and Diagnostic
Standard
All serum samples were tested with glycoprotein G type-specific enzyme
immunoassays from Meridian Diagnostics (Cincinnati, OH) and from MRL
Diagnostics (Cypress, CA) according to the manufacturers' specifications.
All discordant results and 13.7% of the concordant results were tested by
the MRL Immunoblot IgG Assay (MRL Diagnostics) according to the
manufacturer's guidelines.
Main Outcome Measures
The sensitivity, specificity, positive predictive value (PPV), and
negative predictive value (NPV) of each of the EIAs, compared to the
immunoblot assay, were determined.
Main Results
Of the 532 specimens tested by both EIAs, 506 produced EIA-concordant
results (327 HSV-1-positive and 179 HSV-1-negative results). Iimmunoblot
testing confirmed 100% of the 73 EIA-concordant samples tested (25 HSV-1
negative and 48 HSV-1 positive). Twenty-six specimens produced discordant
test results by EIAs Immunoblot testing of the 26 EIA discordant samples
produced 2 false positive, 4 false negative, and 4 equivocal results for
the Meridian kit, and 12 false positive and 6 false negative results for
the MRL kit (table 1). The performances of the 2 EIA tests compared to the
immunoblot assay, calculated using Baye's theorem, are shown in table 2.
| Table 1. Immunoblot
results of 26 HSV EIA discordant results |
|
Immunoblot results |
Meridian Results |
MRL Results |
|
Positive |
Negative |
Equivocal |
Positive |
Negative |
|
Positive |
4 |
4 |
3 |
5 |
6 |
|
Negative |
2 |
12 |
1 |
12 |
3 |
Table 2. Performance characteristics for the Meridian and MRL HSV-1
type-specific EIAs |
|
EIA assay |
Sensitivity |
Specificity |
PPV |
NPV |
|
Meridian |
98.8 |
99.0 |
97.9 |
99.4 |
|
MRL |
98.2 |
93.8 |
96.8 |
96.5 |
Authors' Conclusions
Of the two EIA kits, Meridian's assay had
slightly better overall performance characteristics than the MRL assay.
However, either assay is adequate for patient testing in the laboratory
setting.
Source of funding: Women's Health
Initiative of the Chandler Medical Center Research Fund, University of
Kentucky, Lexington.
For correspondence: Julie Ribes,
University of Kentucky, Department of Pathology and Laboratory Medicine,
MS-117 Medical Center, 800 Rose St., Lexington, KY 40536-0298. E-mail
address: jaribes@uky.edu.
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